UMIN-CTR Clinical Trial

Basic information
Public title	The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Acronym	The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Scientific Title	The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Scientific Title:Acronym	The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of daily drinking of alkaline electrolyzed water (AEW) on health, including gastrointestinal symptoms, when a person without abdominal indefinite complaint.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before the experiment and after the four-week period of every day water drinking, Blood tests, physical fitness evaluations, and questionnaire evaluations is conducted.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Four-week period of every day water drinking, PW drinking group: drink purified tap water
Interventions/Control_2	Four-week period of every day water drinking, AEW drinking group : drink alkaline electrolyzed water which made by electrolysis of purified tap water
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy men and women (20's-60's) medical checkup examinees who visited the Osaka City Citizen Health Development Consultation Center were used as test subjects
Key exclusion criteria	1) If there is a request of the drinking water stop from the subject or the person who has the consent on behalf of the subject 2) If the subject is no longer consulted on the way (we follow up as much as possible about the reasons for no visit.) 3) In addition, if the doctor has determined that the inappropriate continuation of the test
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Nakamura
Organization	Osaka City University Graduate School of Medicine
Division name	Medical informatics & Medical Economics
Zip code
Address	1-4-3 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3788
Email	nhajime@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshinori Tanaka
Organization	Panasonic Corporation, Appliances Company
Division name	Corporate Engineering Division, HA Development Center
Zip code
Address	2-3-1-2 Noji-higashi, Kusatsu Japan
TEL	050-3687-9658
Homepage URL
Email	tanaka.yoshinori@jp.panasonic.com

Sponsor
Institute	Matsushita Electric Works Co., Ltd. Home Appliances R&D Center
Institute
Department

Funding Source
Organization	Matsushita Electric Works Co., Ltd. Home Appliances R&D Center
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	837
Org. issuing International ID_1	ethics committee of Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪市環境保健協会市民健康づくり相談センター

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.medgasres.com/article.asp?issn=2045-9912;year=2018;volume=8;issue=4;spage=160;epage=166;a
Number of participants that the trial has enrolled	40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 01 Month 09 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 19 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036290